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Last Updated: May 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206125


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NDA 206125 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Cipla, Lupin Ltd, Mylan, Piramal Hlthcare Uk, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the CINACALCET HYDROCHLORIDE profile page.

The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 206125
Tradename:CINACALCET HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:cinacalcet hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206125
Medical Subject Heading (MeSH) Categories for 206125
Suppliers and Packaging for NDA: 206125
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 206125 ANDA Aurobindo Pharma Limited 65862-831 65862-831-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-831-01)
CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 206125 ANDA Aurobindo Pharma Limited 65862-831 65862-831-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-831-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 8, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:Mar 8, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Mar 8, 2018TE:ABRLD:No

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